Donepezil 1mg/ml oral solution sugar free

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Donepezil hydrochloride

Διαθέσιμο από:

Rosemont Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

N06DA02

INN (Διεθνής Όνομα):

Donepezil hydrochloride

Δοσολογία:

1mg/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04110000; GTIN: 5016119290893

Φύλλο οδηγιών χρήσης

14.01.16
THREE
301
1 of 2
Black
DONEPEZIL HYDROCHLORIDE 1MG/1ML
ORAL SOLUTION
1MG/1ML
P0820
P0775
-
-
YES
150ML
210 x 300mm (folded 150 x 30mm)
1
Keyline
PACKAGE LEAFLET: INFORMATION FOR THE USER DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION
YOU AND YOUR CAREGIVER SHOULD READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE,
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
■
Keep this leaflet. You may need to read it again.
■
If you have any further questions, ask your doctor or pharmacist.
■
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
■
If you get any of the side effects talk to your doctor or
pharmacist. This includes any possible side effects not listed
in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET:
1. What Donepezil Hydrochloride 1mg/1ml Oral Solution is and what it
is used for
2. What you need to know before you take Donepezil Hydrochloride
1mg/1ml Oral Solution
3. How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6. Contents of the pack and other information
1. WHAT DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION IS AND WHAT
IT IS USED FOR
Donepezil belongs to a group of medicines called acetylcholinesterase
inhibitors.
It is used to treat the symptoms of dementia in people diagnosed as
having mild to moderately severe Alzheimer’s
disease. The symptoms include increasing memory loss, confusion and
behavioural changes. As a result, sufferers
of Alzheimer’s disease find it more and more difficult to carry out
their normal daily activities.
Donepezil Hydrochloride 1mg/1ml Oral Solution is for use in adult
patients only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE
1MG/1ML
ORAL SOLUTION
DO NOT TAKE DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION:
■
if you are allergic to (hypersensitive) to donepezil hydrochloride, or
to piperidine derivatives, or any of

Αρχείο Π.Χ.Π.

OBJECT 1
DONEPEZIL HYDROCHLORIDE 1MG/1ML ORAL SOLUTION
Summary of Product Characteristics Updated 07-Jun-2016 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Donepezil Hydrochloride 1mg/1ml Oral Solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 1mg donepezil hydrochloride
Excipients with known effect:
D-Sorbitol 70% solution (E 420) 357mg/ml
Methyl parahydroxybenzoate (E 218) 1mg/ml
Sodium metabisulphite (E223) 0.2mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
A clear colourless liquid with a strawberry odour that is essentially
free from visible foreign matter.
4. Clinical particulars
4.1 Therapeutic indications
Donepezil is indicated for the symptomatic treatment of mild to
moderately severe Alzheimer's dementia.
4.2 Posology and method of administration
Posology
Adults/Elderly:
Treatment is initiated at 5 ml (5 mg)/day (once-a-day dosing) by
filling the dosing spoon to the line of
5ml. Donepezil Hydrochloride 1mg/1ml Oral Solution should be taken
orally, in the evening, just prior to
retiring, and can be taken with or without food.
The 5 mg/day dose should be maintained for at least one month in order
to allow the earliest clinical
responses to treatment to be assessed and to allow steady-state
concentrations of donepezil hydrochloride
to be achieved. Following a one-month clinical assessment of treatment
at 5 mg/day, the dose of
Donepezil Hydrochloride 1mg/ml Oral Solution can be increased to 10 ml
(10 mg)/day (once-a-day
dosing), by filling the dosing spoon to the line of 10ml. The maximum
recommended daily dose is 10 mg.
Doses greater than 10 mg/day have not been studied in clinical trials.
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of
Alzheimer's dementia. Diagnosis should be made according to accepted
guidelines (e.g. DSM IV, ICD
10). Therapy with donepezil should only be started if a caregiver is
available who will regularly monitor
drug intake